Perspectives on Global Design

For your area of the industry, what is the most significant
consideration when designing a device for use both domestically and
internationally?

Ken Appel VP Regulated Markets, Veriteq Instruments

The sorts of medical devices that are designed and manufactured with the help of Veriteq technology for temperature and humidity monitoring, alarming, and reporting–Class I to III devices requiring sterile manufacturing conditions and sterile packaging–can always be regarded as up to ALL international standards if they meet U.S. FDA’s requirements.

The bigger issue is whether the globally distributed manufacturing model that is taking hold in the device industry can reliably replicate the “clean” conditions under which devices are designed domestically. Product or component manufacturing and packaging for devices used for patient implants and diagnostics, for example, must be made in contamination-controlled environments where records of environmental conditions are available for inspection to FDA and ISO 13485 regulations. This can be challenging for cleanrooms in developing nations where power infrastructures may be fragile. This probably goes a long way to explain why Veriteq’s data loggers with redundant recording and data backup features to ensure gap-free records for any time period are in growing demand by medical device companies that both manufacture and sell worldwide.

Patrick YiFounder and CEO, MediPurpose Inc.

The single most important consideration when designing a device for use both domestically and internationally is to develop a base design that allows localization and expansion with minimal design and production cost. The trick to doing this well is to plan for it from the beginning.To understand local practices and requirements, VOC (voice of customer) research should be conducted in representative countries to document similarities and differences in usage, sizes, and language.

Use international symbols whenever possible–controls, buttons, and labels. This makes it easier to have a product that is understandable with fewer words that must be differentiated. There are international standards that capture these symbols, such as ANSI/AAMI/ISO 15223-1:2007. This can allow the “base” unit to be identical, allowing localization by adding specific-language software, instructions, and country-specific power cords.Allow for the differences in various languages in terms of number of words needed to describe something, as well as the difference in length of words. This can affect display selection, user interface organization, packaging, and instructions for use. Some languages require as much as 23 languages on the packaging for the EU.

In today’s economic climate, the first step is to truly understand why you are designing a device for domestic and international use. For most medical devices, more than 50% of sales are likely to occur within the U.S. Furthermore, capturing the U.S. market has proven essential to success internationally. If international licensing is merely a stepping stone to the true U.S. prize, is it worth the effort? If the intended device’s international market is viable on its own, must its U.S. product be the same design, or do the reimbursement model, regulatory constraints, and different customer profiles demand that it be different? And if so, how different?

Increasingly, companies are finding that redesigning one product to fit multiple purposes is not only more difficult but also more time consuming and more expensive. Invariably, shortcuts taken in product and process design return to bite, as FDA guidelines demand significant changes that may question the original proof of principle for its international counterpart. Indeed, gone are the days when VCs would snap up a device with international approval and a seemingly solid business case domestically; maybe the traditional model of international first and domestic second also needs more thought?

Herm HarrisonVP, Foster Transformer Co.

In terms of transformers or power supplies, the most important consideration is designing a product that complies with the oft differing safety agency requirements. This has become somewhat simpler for medical devices since Underwriters Laboratories has harmonized its standard with the EN Standard (which traces back to the IEC and VDE standards).

However, a few differences in the way we approach electrical safety remain. Products geared towards North America, for the most part, remain focused on reducing the fire hazard posed by electrical devices (dating back to the founding of Underwriters Laboratories by the Insurance Industry following the Great Chicago Fire). In the rest of the world, however, more attention is paid to minimizing the electrical shock hazard. This is due in large part to the fact that Europe and other parts of the world have a nominal line voltage that is twice what we see in the United States.

Jacques HoffmannPresident, InterTech Development Co.

For those of us who have been involved helping companies engineer assembly and test operations worldwide for many years that meet ISO 13485-2003 standards, it is somewhat alarming to still hear rumors that, in certain countries, ISO certifications are available for purchase.As an assurance to both domestic and international consumers, InterTech Development Co. can report that ALL of the leading medical device manufacturers that we serve have been meticulous in ensuring that no such shortcuts are taken. And, especially for the growing number of devices that are designed to be used in home environments by patients themselves, the testing of devices during assembly is far more extensive to ensure that all persons, with all skill levels, can operate devices seamlessly. This happens first on the design level and then is reinforced by extensive testing during manufacture. This requirement makes devices “trans-national.”

By combining error-proofing techniques with high performance test instrumentation, InterTech’ applications engineers are enabling many device manufacturers to now take better advantage of low-cost labor in China up to 75% lower lifetime costs of operation<md>while delivering devices built to the ISO 13485-2003 quality standards with which they were designed.

Lance HeftCEO, International Tube

Quality and valueit is our duty and responsibility to help device companies develop a product that is quality driven, that can be brought to market safely, and still have a reasonable cost. If you do not provide a product that meets all of these criteria, you cannot enhance your customers offerings, and provide the end user (and ultimately the patient) with a product that will meet their needs.

If a product is not designed and manufactured with quality first, the long term costs can be astronomical. We attempt to discern the true needs of the customer, and manufacture a product that meets and exceeds those needs at a reasonable cost.

Tim MortonDesign Director, Product Development Technologies

When designing for both domestic and international use, it is
essential to invest many hours prior to engaging in a program by planning
resources, goals, deliverables and benchmarks. Research activities are the most
significant consideration, as it allows a designer to focus on establishing an
impartial and holistic view of the product and its potential uses. For example,
our teams will consider the industry, end-users and product lifecycle in order
to identify opportunities to maximize comfort and usability while at the same
time minimize cost and complexity.

Knowledge of the various approval processes and requirements
to bring a device to market are thus key to developing a successful device that
can be leveraged across the globe. It is also important to understanding that
end-of-life disposal and impact considerations vary based on where the product
is used.

As such, our teams work closely throughout each program so
if an electrical designer identifies opportunities for design based on
firsthand observation, it can influence the path to success at a very early
stage. This strategy can be very valuable when designing products for global
use. It is a foundation of our 'informed innovation' process.